MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

This Phase IV randomized, double-blind, placebo-controlled clinical trial was “designed to demonstrate the efficacy and safety of the product Neurodoron (Kalium phosporicum comp., KPC) in patients with neurasthenia”.

The study was conducted in an outpatient German trial site. Women and men aged 18 and above were randomized to receive either KPC or placebo if they reported typical symptoms of neurasthenia and a severe psychiatric disorder could be excluded. The primary objectives were a reduction in characteristic symptoms of nervous exhaustion and perceived stress as well as improvement in general health status after 6 weeks of treatment.

In total, 204 patients underwent screening, 78 were randomized in each treatment group, and 77 patients each received treatment (intention-to-treat (ITT) population = 154 patients). For none of the primary efficacy variables, an advantage in favor of KPC could be demonstrated in the pre-specified analysis (p-values between 0.505-0.773, Student’s t-test). In a post-hoc analysis of intra-individual differences after 6 weeks treatment, a significant advantage of KPC vs. placebo was shown for characteristic symptoms of nervous exhaustion (irritability (p = 0.020); nervousness (p = 0.045), Student’s t-test). Adverse event (AE) rates were similar between treatment groups, in both groups six AEs were assessed as causally related to treatment (severity mild or moderate). No AE resulted in discontinuation of treatment.

The authors concluded that the trial treatment was well tolerated with only a few and minor AEs reported, confirming the markedly good safety of KPC. A significant improvement of neurasthenia was seen for the total study population at the end of the treatment period. Superiority of KPC vs. placebo could not be demonstrated with the pre-specified analysis with regards to a sum score of 12 typical symptoms, perceived stress, or general health status. However, the explorative post-hoc analysis revealed that KPC is superior to placebo in the characteristic symptoms irritability and nervousness. KPC could therefore be a beneficial treatment option for symptomatic relief of neurasthenia.

The very first thing one notices is the aim of the study. According to its authors, it was “designed to demonstrate the efficacy and safety of the product Neurodoron (Kalium phosporicum comp., KPC) in patients with neurasthenia“. Any group of researchers that is unaware of the fact that clinical trials are for TESTING and not for DEMONSTRATING should, in my view, be sent straight back to school. And while they are at it, they might as well take with them the editor of the journal as well as the peer-reviewers of the paper.

As it happens, I have published a post about Neurodoron before. Here is a short section from it:

Stress is associated with a multitude of physical and psychological health impairments. To tackle these health disorders, over-the-counter (OTC) products like Neurodoron® are popular since they are considered safe and tolerable. One tablet of this anthroposophic remedy contains the following active ingredients:

83.3 mg Aurum metallicum praeparatum trituration (trit.) D10,

83.3 mg Kalium phosphoricicum trit. D6,

8.3 mg Ferrum-Quarz trit. D2.

Experience reports and first studies indicate that Neurodoron® is efficient in the treatment of stress-associated health symptoms…

Apart from its above-mentioned aim, the new study is remarkable in one further aspect: in its conclusion, it makes a big deal out of the ‘good news’ that Neurodoron safe. As the trial was not designed to test safety, this can only be seen as an attempt to hide (as well as possible) the fact that the remedy turned out to be ineffective.

Why would researchers try to distract the reader from the main message of their work? The answer might lie in the affiliation of two of the authors: Clinical Research, Weleda AG, Schwäbisch Gmünd, Germany.

14 Responses to Neurodoron, the anthroposophic remedy for neurasthenia, is unsurprisingly useless

  • I’m surprised to see that awful journal still exists. Back in the day it was the the one you went to if you were absolutely desperate to get the paper published and everybody else had rejected it.

  • Another waste of money trial when this product will sell anyway. Why do these companies persist in clinical trials when us punters will just buy the stuff.

    Anyway someone told me that there was this Neurodoron product around that contains Gold. Well being into CAM and obviously only concerned about money I dropped everything to buy as much as possible.
    Unfortunately my sources were non evidence based rumours rather than the evidence based anecdotal gossip that I usually rely on. On evaluation i realised that the Gold (Aurum) was added at D10 level.
    This means that 1000Kg would only contain 0.1g of Gold.
    My get rich quick plans have again been thwated and all i have now are 1000s of pots of Neurodoron.
    I might market it as a ‘quantum’ product as that might help shift it.

    • ‘JK’ asserted: “This means that 1000Kg would only contain 0.1g of Gold.”

      Not bad: on this occasion, you are in error by only 3½ orders of magnitude.

      • @Pete Attkins, JK
        It’s pretty simple:
        83.3 mg of a 1:10¹⁰ dilution of gold = 8.33 picograms of gold.
        So a thousand kilograms would be about 12 million times as much = 100 micrograms, so it’s pretty close to being 3 orders of magnitude off.

        Of course all this is a complete waste of human intelligence, as is anything to do with homeopathy or anthroposophic nonsense.

        • Oh dear!

          EACH 250 mg TABLET of Weleda AG Neurodoron® contains:
          1. Aurum metallicum 10 DH up to 83.3 mg;
          2. Ferrum sulfuricum – Silicea 2 DH up to 8.3 mg;
          3. Kalium phosphoricum 6 DH up to 83.3 mg;
          4. excipients wheat starch & lactose: 250−2×83.3−8.3=75.1 mg.

          Per gram of TABLET:
          1. 83.3 mg / 250 mg × 1E−10 ≈ 33 pg/g
          2. …

          ∴ 1 tonne of TABLETS has up to 33 μg gold;
            3½ orders of magnitude below the 0.1 g asserted by ‘JK’.

  • If I’m not mistaken, Kalium phosphoricicum trit. D6 is probably just tripotassium phosphate (K3PO4) in a dilution of one part per million, and 83.3 milligrams of this means a total dose of 83.3 nanograms.

    Upon dissolving or ingestion, K3PO4 immediately dissociates into potassium ions and phosphate ions – both of which we already ingest in pretty large quantities (several grams) on a daily basis. So an extra 83.3 nanograms can’t possibly do anything at all.

    This is in other words just as stupid as those homeopaths who claim that the endlessly diluted ghost of ordinary table salt (‘Natrium muriaticum’) has special medicinal properties. The only difference being that with this potassium stuff you still get a few molecules – not that it makes any difference, of course.

  • The Kali phos is potentised Richard . Its a kind of magic.
    If you think that ‘there is no such thing as magic’ then you are just like Harry Potter’s Uncle Vernon. In this scenario Homeopathy is Harry Potter. Edzard is Dudley.

    • @JK

      The Kali phos is potentised

      That’s just homeospeak for ‘diluted’.

      Its a kind of magic.

      I guess you’re right. Which implies that homeopaths etc. have the intelligence level of a 6-year-old.

    • Magic or snake oil? I think it’s one and the same, as long as people are buying them by gallons. Salesmen on the other hand are driving away with chestfull of cash.

  • This was a phase 4 trial. Ie Post marketing surveillance.
    Maybe they will now sell millions of Neurodoron and there will be chestfulls of cash around as Talker says.
    It could be that they aren’t wasting money on research after all.
    I look forward to seeing this product marketed in the UK.
    You might have to get used to this sort of thing happening

    • ‘JK’ wrote: “I look forward to seeing this product marketed in the UK”.

      From the paper [my bolding]:

      …the product Neurodoron (Kalium phosporicum comp., KPC) …

      According to anthroposophic pharmaceutical principles, Dr. Kurt Magerstaedt developed KPC in the early 1950s to support people to better cope with exam stress. In 1954, the product was first launched in Germany, followed by Switzerland, Austria, France, Ukraine, Italy, and the UK. Worldwide, ∼ 300,000 units are sold per year.

    • JK opines:”It could be that they aren’t wasting money on research after all…You might have to get used to this sort of thing happening.”

      I happen to agree. Why waste money on research when a snakeoil salesman can fleece an unsuspecting victim off their hard earned cash? Perhaps we should get used to this sort of thing happening more often. Why bother keeping the beat cop and the journalist on payroll, when the burglar gets away with it often? We should all get used to burglars burgling their way through town.

      I for one am content with my nightly dose of snakeoil and keeping my doors wide open to give burglars easy access. I might even put up a neon sign with an arrow pointing to my house, saying “Please burgle my house Mr. Burglar!”

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